Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Xylometazoline hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Otrivine Adult Nasal Drops are for application in the nose to give relief from:
2. BEFORE YOU USE OTRIVINE ADULT NASAL DROPS DO NOT use the drops if you:
V2
09 – Mar – 2023
D2A
Non Production
Production
AWP No:
X TR2767483/B
Site Component No:
Nyon
62000000203002
Approving Market:
1.
Black
20%
Total Special Finishes: 0
OTRIVINE ADULT NASAL DROPS Dosage: For Adults and Children over 12 years of age: 2 to 3 drops in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril. 62000000203002
Site Change Control No: 201227617
OTRIVINE OTRIVINE
Leaflet
Technical Drawing No:
Material Spec No:
N-PN-P08 v2.1
P08
Print Process:
Pharma Code No:
Offset – Lithography
474
Barcode No:
Bar Width Reduction:
N/A
N/A
Formulation Code
Body Text Size: 8.8pt Leading: 9.2pt Horizontal Scale: 100% Smallest Text Size: 8.8pt
Micro Text: No
Studio Location: Europe
treatment
Like other products for relief of blocked nose, Otrivine may give rise to sleep disturbances, dizziness, tremor in very sensitive patients. Consult your doctor if such signs prove to be troublesome. Do not take decongestants for more than 7 days in a row. Prolonged or excessive use may cause stuffiness in the nose to return or worsen. Using other medicines Please tell your doctor or pharmacist before using this product if you are taking or have recently taken any medicines (especially monoamine oxidase inhibitors or other antidepressants) including those obtained without a prescription. Pregnancy or breast-feeding If you are pregnant or breast-feeding, consult your doctor before using Otrivine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Otrivine has no effect on the ability to drive and use machines. Important information about some of the ingredients Otrivine contains benzalkonium chloride which may cause nasal irritation.
Product Market Trade Name: Component Type:
N/A
AIP_CHAMPS_2022_HALEON_Version 1
Take special care Before using the drops tell your doctor if you:
CHAMPS No: 0000014938
Manufacturing Site:
Great Britain 50%
Do not use these drops for children under 12 years old.
Artwork Information Panel
Total Number of Colours including Varnish & Foils: 1
70%
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 474 100 0 Micrometre
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 474 100 0 Micrometre
Verso Recto 62000000123456
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Administration: 1. Clear your nose. 2. Lean head back as far as is comfortable (see diagram). 3. Apply the drops into each nostril and keep head back for a short time. 4. Clean and dry the dropper before replacing it back. To avoid possible spread of infection, this pack should only be used by one person. For reasons of hygiene do not use this bottle for more than 28 days after opening it. Do not exceed the recommended dosage, especially in children and elderly. If you use more Otrivine Adult Nasal Drops than you should, consult your doctor or pharmacist.
Like all medicines, Otrivine Adult Nasal Drops can cause side effects, although not everybody gets them. Stop using Otrivine Adult Nasal Drops and seek medical help immediately if you experience:
OTRIVINE ADULT NASAL DROPS Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the bottle after "Expiry". The expiry date refers to the last day of that month. Protect from heat. Do not use this bottle for more than 28 days after opening it. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Otrivine Adult Nasal Drops contain The active ingredient is xylometazoline hydrochloride (0.1% w/v). The other ingredients are sodium chloride, sodium phosphate, sodium acid phosphate, disodium edetate, benzalkonium chloride, sorbitol, hypromellose and water. What Otrivine Adult Nasal Drops look like and the contents of the pack Otrivine Adult Nasal Drops are a clear, colourless aqueous solution packed in 10ml bottles. Marketing authorisation holder Haleon UK Trading Limited, Weybridge, KT13 0NY, U.K. Manufacturer
Haleon UK Trading Services Limited, Weybridge, KT13 0NY, U.K.
This leaflet was last revised in February 2024. Trade Marks are owned by or licensed to the Haleon group of companies.
Other side effects include:
V2
09 – Mar – 2023
D2A
Artwork Information Panel Non Production
Total Number of Colours including Varnish & Foils: 1
Production
AWP No:
X TR2767483/B Manufacturing Site:
Site Component No:
Nyon
62000000203002
Approving Market: Great Britain 70%
1.
50%
Black
20%
Total Special Finishes: 0
OTRIVINE OTRIVINE
Leaflet
Technical Drawing No:
Material Spec No:
N-PN-P08 v2.1
P08
Print Process:
Pharma Code No:
Offset – Lithography
474
Barcode No:
Bar Width Reduction:
N/A
N/A
Formulation Code
Body Text Size: 8.8pt Leading: 9.2pt Horizontal Scale: 100% Smallest Text Size: 8.8pt
Micro Text: No
Studio Location: Europe
Site Change Control No: 201227617
Product Market Trade Name: Component Type:
N/A
AIP_CHAMPS_2022_HALEON_Version 1
CHAMPS No: 0000014938
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 474 100 0 Micrometre
BARCODE INFO Barcode Type Barcode Number: Magnification: BWR:
Pharmacode Standard 474 100 0 Micrometre
Otrivine Adult Nasal Drops comes as nasal spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Otrivine Adult Nasal Drops is xylometazoline hydrochloride.
Medicines with the same active substance, strength and form include: Otrivine Allergy Relief 0.1% Nasal Spray with Khone Spray, Otrivine Blocked Nose Relief, 0.1% w/v Nasal Spray, Solution, Otrivine Child Nasal Drops. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Otrivine Adult Nasal Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.
Adults and elderly (all indications): 2 or 3 drops in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.
The drops are suitable for children over 12 years of age. The recommended dose should not be exceeded, especially in children and the elderly.
Route of administration: Nasal use.
Known hypersensitivity to Otrivine
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater
Narrow-angle glaucoma
Rhinitis sicca or atrophic rhinitis.
Otrivine 0.1% is contraindicated in children aged less than 12 years
People with phaeochromocytoma or prostatic hypertrophy or receiving monoamine oxidase inhibitors (MAOI) treatment or who have received them in the last two weeks.
Patients are advised not to take decongestants for more than seven consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus or tri and tetra-cyclic antidepressant treatment (see Interactions).
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Keep medicines out of the sight and reach of children
Information concerning excipients
Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (see Contraindications).
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.
Otrivine has no or negligible influence on the ability to drive and use machines.
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) or very rare (<1/10,000).
MeDRA SOC
Adverse reaction
Frequency
Immune System Disorders
Hypersensitivity reaction (angioedema, rash, pruritus)
Very rare
Nervous System Disorders
Headache
Common
Eye Disorders
Transient visual impairment
Very rare
Cardiac Disorders
Heart rate irregular
Heart rate increased
Very rare
Very rare
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
Nasal Discomfort
Epistaxis
Common
Common
Uncommon
Gastrointestinal disorders
Nausea
Common
General disorders and administration site
Application site burning
Common
Other side effects include:
• A burning sensation in the nose and throat
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
Symptoms and signs
Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.
Treatment
Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours.
Ask anything about Otrivine Adult Nasal Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.